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Mobile health app developers take note – the importance of patient safety

24 November 2017. Published by Ella Shanks, Trainee Solicitor

The benefits of mobile health apps are plenty. However, developers must be aware of their responsibility to users to ensure apps are safe and effective.

Mobile health, or mHealth, is the term used for the growing industry of medicine and public health supported by mobile devices. Some forecasts predict the global mHealth market will be worth over $102bn by 2022, and that over 50% of smartphone users will download an app in 2018. In February 2017 a mobile app called 'Natural Cycles' became the first app certified as a medical device for contraception in the EU and thrust mHealth into the news and public conversation. However, many apps are not subject to regulation and, as healthcare is increasingly put into the phone and hands of individuals, developers must take responsibility for ensuring patient safety.

'Natural Cycles' uses an algorithm to establish a woman's fertility. Users are asked to input their temperature each morning and the app designates the day as either 'red', meaning the user is fertile, or 'green'. It then advises the user to abstain or take other precautions on the 'red' days to avoid falling pregnant.

'Natural Cycles' is classified by the Medicines and Healthcare products Regulatory Agency (MHRA) as a 'medical device', meaning that it will have had to evidence full compliance with EU regulation and meet stringent testing requirements to obtain approval. 'Natural Cycles' co-founder, Raoul Scherwitzl, said that the app was granted certification in the EU having demonstrated, during clinical studies, that it improves the effectiveness of traditional contraception. The app does have a reduced failure rate in comparison to other contraceptive methods, but the technology is not 100% fool proof. Out of 4054 women who took part in the clinical study, there were 143 identified unplanned pregnancies. Of these, 10 were due to the app wrongly assuring women that they were not fertile on a particular day.

The growing prevalence of mHealth is not limited to contraception. In November 2017, the NHS announced that it was rolling out a pilot scheme called 'GP at Hand' to 3.5 million Londoners. 'GP at Hand' enables patients to check their symptoms through an app, and if necessary, connect to a GP via video within 2 hours. 

'GP at Hand' is not classified as a 'medical device' by the MHRA because it falls short of making medical diagnoses; instead it analyses symptoms and provides a recommended timeframe in which to seek a doctor's opinion. This means that, unlike 'Natural Cycles', the app does not need certification by a notified body before it can be promoted to patients. 

A relatively small proportion of the many mHealth apps on the market are classified as 'medical devices' by the MHRA, but, as apps become ever more advanced to meet users' demands, developers will need to be aware of the MHRA requirements and, if necessary, ensure their apps are fully compliant.

For those apps which are not regulated by medical device legislation, developers should nevertheless always bear in mind that patient safety is at stake and take all necessary steps to mitigate risks. Even with an app like 'GP at Hand', it's not difficult to imagine a scenario in which a patient with a serious illness is falsely told there's no urgent need to see a doctor, with potentially life-threatening consequences.

Practical steps for developers:

  • Undertake extensive testing to assess the level of risk.
  • Be aware of any regulatory requirements, particularly as apps become more advanced and diagnostic in nature.
  • Ensure that clinicians are involved in the development process throughout so that medical risks can be identified accurately.
  • Give users comprehensive instructions for use and guidance to help eliminate user error.
  • Include product warnings to alert users to the risks of over-reliance on the app in place of appropriate clinician review.